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The Efficacy of risperidone oral solution for reducing the incidence of postoperative delirium in vascular patients: a randomized controlled trial

The Efficacy of risperidone oral solution for reducing the incidence of postoperative delirium in vascular patients: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190704003
Enrollment
Unknown
Registered
2019-07-04
Start date
2019-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vascular patients postoperative delirium&#44

Interventions

The placebo arm a distilled water 0.5 ml,The risperidone arm a risperidone oral solution 0.5 mg (0.5 mL)
Placebo,risperidone oral solution

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. patients aged > 60 years 2. undergoing elective vascular surgery 3. operative time > 2 hours.

Exclusion criteria

Exclusion criteria: 1. patients with cognitive impairment (a Thai Mental State Examination score < 24) 2. evidence of alcohol abuse 3. alcohol ingestion occurring in the 14&#45;day period preceding the surgery 4. preoperative delirium (shown by a positive result with the Confusion Assessment Method for the Intensive Care Unit&#44; CAM&#45;ICU) 5. severely impaired renal function (demonstrated by a creatinine clearance < 30 mL/min/1.72 m2) 6. hepatic impairment (a Child Pugh score ≥ 10) 7. allergy to risperidone 8. neuroleptic malignant syndrome

Design outcomes

Primary

MeasureTime frame
delirium Admitted to an SICU for a period that was expected to be longer than 24 hour The CAM−ICU score

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactOrawan Pongraweewan

Faculty of Medicine Siriraj Hospital&#44; Mahidol University

Orawan.pon@mahidol.ac.th024197978

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026